MAUDE Adverse Event Report: COVIDIEN SURGICAL RELIATACK; STAPLE, IMPLANTABLE

Model Number	RELTACK4XDPT
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Unintended Radiation Exposure (4565)
Date of Event	10/21/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
According to the reporter, in a laparoscopic incarcerated ventral hernia repair, the pin on the tacker that holds the reloads broke off when firing and fell into the patient¿s cavity.X-ray was done for the express purpose of locating the component or confirming that all pieces were located.The procedure was delayed for 45 minutes due to the x-ray.The pin was found and a new tacker was used.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted that the pin on the tacker used to hold the reloads was broken off; the fasteners were received, and no sulus (single use loading unit) were returned.During evaluation, the articulation knob was nonfunctional and jammed in partial articulation; however, the handle was able to be actuated and cycled properly with no sulu loaded.It was reported that in a laparoscopic incarcerated ventral hernia repair, the pin on the tacker that holds the reloads broke off when firing and fell into the patient¿s cavity.X-ray was done for the express purpose of locating the component or confirming that all pieces were located.The procedure was delayed for forty five minutes due to the x-ray.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.This issue may occur due to excessive manipulation of the device, in this case over torquing of the knob.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.A secondary review of the device history records found no potentially contributing factors.The instructions included with this device provide the following guidance: appropriate force should be applied to the handle of the device when placing tacks.Excessive force may result in damage to the tissue, device and/or the material being fixated.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: RELIATACK
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN SURGICAL; 60 middletown ave; north haven CT 06473
• Manufacturer (Section G): COVIDIEN SURGICAL; 60 middletown ave; north haven CT 06473
• Manufacturer Contact: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 23539702
• Report Number: 1219930-2025-05272
• Device Sequence Number: 13205471
• Product Code: GDW
• UDI-Device Identifier: 10884521202429
• UDI-Public: (01)10884521202429(17)271031(10)N5A1787Y
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K151659
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: RELTACK4XDPT
• Device Catalogue Number: RELTACK4XDPT
• Device Lot Number: N5A1787Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2025
• Supplement Date Received by Manufacturer: 04/23/2026
• Initial Report FDA Received Date: 11/13/2025
• Supplement Report FDA Received Date: 04/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/25/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 69 YR
• Patient Sex: Female